Clinical Safety of a Viral Vector Based Prostate Cancer Vaccine Strategy

Arlen, Philip M.; Skarupa, Lisa; Pazdur, Mary; Seetharam, Mahesh; Tsang, Kwong Y.; Grosenbach, Douglas W.; Feldman, Jarett L.; Poole, Diane J.; Litzinger, Mary; Steinberg, Seth M.; Jones, Elizabeth; Chen, Clara; Marté, Jennifer L.; Parnes, Howard L.; Wright, John J.; Dahut, William L.; Schlom, Jeffrey; Gulley, James L.

doi:10.1016/j.juro.2007.05.117

Cited by 109 publications

(73 citation statements)

References 17 publications

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“…PROSTVAC-VF has been tested clinically in two phase I studies, 7,8 and one single-arm phase II study. Both phase I studies demonstrated safety of the vectors, and the National Cancer Institute (NCI) study also evaluated biodistribution kinetics.…”

Section: Journal Of Clinical Oncology O R I G I N a L R E P O R T V Omentioning

confidence: 99%

Overall Survival Analysis of a Phase II Randomized Controlled Trial of a Poxviral-Based PSA-Targeted Immunotherapy in Metastatic Castration-Resistant Prostate Cancer

Kantoff

Schuetz

Blumenstein

et al. 2010

JCO

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881

724

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A B S T R A C T PurposeTherapeutic prostate-specific antigen (PSA) -targeted poxviral vaccines for prostate cancer have been well tolerated. PROSTVAC-VF treatment was evaluated for safety and for prolongation of progression-free survival (PFS) and overall survival (OS) in a randomized, controlled, and blinded phase II study. Patients and MethodsIn total, 125 patients were randomly assigned in a multicenter trial of vaccination series. Eligible patients had minimally symptomatic castration-resistant metastatic prostate cancer (mCRPC). PROSTVAC-VF comprises two recombinant viral vectors, each encoding transgenes for PSA, and three immune costimulatory molecules (B7.1, ICAM-1, and LFA-3). Vaccinia-based vector was used for priming followed by six planned fowlpox-based vector boosts. Patients were allocated (2:1) to PROSTVAC-VF plus granulocyte-macrophage colony-stimulating factor or to control empty vectors plus saline injections. ResultsEighty-two patients received PROSTVAC-VF and 40 received control vectors. Patient characteristics were similar in both groups. The primary end point was PFS, which was similar in the two groups (P ϭ .6). However, at 3 years post study, PROSTVAC-VF patients had a better OS with 25 (30%) of 82 alive versus 7 (17%) of 40 controls, longer median survival by 8.5 months (25.1 v 16.6 months for controls), an estimated hazard ratio of 0.56 (95% CI, 0.37 to 0.85), and stratified log-rank P ϭ .0061. ConclusionPROSTVAC-VF immunotherapy was well tolerated and associated with a 44% reduction in the death rate and an 8.5-month improvement in median OS in men with mCRPC. These provocative data provide preliminary evidence of clinically meaningful benefit but need to be confirmed in a larger phase III study.

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Section: Journal Of Clinical Oncology O R I G I N a L R E P O R T V Omentioning

confidence: 99%

Overall Survival Analysis of a Phase II Randomized Controlled Trial of a Poxviral-Based PSA-Targeted Immunotherapy in Metastatic Castration-Resistant Prostate Cancer

Kantoff

Schuetz

Blumenstein

et al. 2010

JCO

Self Cite

881

724

View full text Add to dashboard Cite

show abstract

“…49 The vaccinia virus-based vector is used for priming and is followed by fowl pox virus-based vector boosts. This helps to overcome the host anti-vector antibody responses to the original vector.…”

Section: Viral-based Vaccinesmentioning

confidence: 99%

A primer on tumour immunology and prostate cancer immunotherapy

Ren

Koti

Hamilton

et al. 2016

CUAJ

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“…This approach has been tested clinically in a number of phase I studies demonstrating safety of the vectors (Sanda et al, 1999;DiPaola et al, 2006;Arlen et al, 2007), and three phase II studies. Prostvac-VF consists of two genetically engineered viruses (recombinant Vaccinia (V) virus and Fowl pox (F) virus) administered in a sequential regimen.…”

Section: Prostvac-vf Approachmentioning

confidence: 99%

Entering a New Era – Prostate Cancer Immuno-Therapy After the FDA Approval for Sipuleucel-T

Brill¹

2011

Prostate Cancer - Diagnostic and Therapeutic Advances

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Clinical Safety of a Viral Vector Based Prostate Cancer Vaccine Strategy

Abstract: Based on the safety and preliminary immunogenicity results of this trial we recommend initiating a randomized, phase II study of prostate specific antigen/triad of co-stimulatory molecules vaccines in patients with less advanced prostate cancer.

Cited by 109 publications

References 17 publications

Overall Survival Analysis of a Phase II Randomized Controlled Trial of a Poxviral-Based PSA-Targeted Immunotherapy in Metastatic Castration-Resistant Prostate Cancer

Overall Survival Analysis of a Phase II Randomized Controlled Trial of a Poxviral-Based PSA-Targeted Immunotherapy in Metastatic Castration-Resistant Prostate Cancer

A primer on tumour immunology and prostate cancer immunotherapy

Entering a New Era – Prostate Cancer Immuno-Therapy After the FDA Approval for Sipuleucel-T

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